United States Government Publishing Office publisher pbl distributor dst United States National Archives and Records Administration Office of the Federal Register author aut Government Organization text government publication eng FR Regulatory Information 2015_register executive 2015-11-26 article Part III Rules and Regulations D09002ee1c7f6d97d D09002ee1c7f6daa7 United States Department of Health and Human Services originator org United States Government Agency or Subagency United States Food and Drug Administration originator org United States Government Agency or Subagency To minimize the risk of serious adverse health consequences or death from consumption of contaminated produce, the Food and Drug Administration (FDA or we) is establishing science-based minimum standards for the safe growing, harvesting, packing, and holding of produce, meaning fruits and vegetables grown for human consumption. FDA is establishing these standards as part of our implementation of the FDA Food Safety and Modernization Act. These standards do not apply to produce that is rarely consumed raw, produce for personal or on-farm consumption, or produce that is not a raw agricultural commodity. In addition, produce that receives commercial processing that adequately reduces the presence of microorganisms of public health significance is eligible for exemption from the requirements of this rule. The rule sets forth procedures, processes, and practices that minimize the risk of serious adverse health consequences or death, including those reasonably necessary to prevent the introduction of known or reasonably foreseeable biological hazards into or onto produce and to provide reasonable assurances that the produce is not adulterated on account of such hazards. We expect the rule to reduce foodborne illness associated with the consumption of contaminated produce. 80 FR 74354 https://www.govinfo.gov/app/details/FR-2015-11-27/2015-28159 2015-28159 fr27no15-20 RIN 0910-AG35 4164-01-P Docket No. FDA-2011-N-0921 https://www.govinfo.gov/app/details/FR-2015-11-27/2015-28159 https://www.govinfo.gov/content/pkg/FR-2015-11-27/html/2015-28159.htm https://www.govinfo.gov/content/pkg/FR-2015-11-27/pdf/2015-28159.pdf Administrative Practice and Procedure Computer Technology Reporting and Recordkeeping Requirements Foods Fruits and Vegetables Incorporation by Reference Packaging and Containers Recordkeeping Requirements Safety 215 p. 74354 74568 80 FR 74354 Title 21 Part 112 21 CFR Part 112 Title 21 Part 11 21 CFR Part 11 Title 21 Part 16 21 CFR Part 16 RIN 0910-AG35 Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption; Federal Register Vol. 80, Issue RULE 2015-28159 III DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 2016-01-26 2016-01-26 Docket No. FDA-2011-N-0921 4164-01-P 2015-28159 Final rule.

To minimize the risk of serious adverse health consequences or death from consumption of contaminated produce, the Food and Drug Administration (FDA or we) is establishing science-based minimum standards for the safe growing, harvesting, packing, and holding of produce, meaning fruits and vegetables grown for human consumption. FDA is establishing these standards as part of our implementation of the FDA Food Safety and Modernization Act. These standards do not apply to produce that is rarely consumed raw, produce for personal or on-farm consumption, or produce that is not a raw agricultural commodity. In addition, produce that receives commercial processing that adequately reduces the presence of microorganisms of public health significance is eligible for exemption from the requirements of this rule. The rule sets forth procedures, processes, and practices that minimize the risk of serious adverse health consequences or death, including those reasonably necessary to prevent the introduction of known or reasonably foreseeable biological hazards into or onto produce and to provide reasonable assurances that the produce is not adulterated on account of such hazards. We expect the rule to reduce foodborne illness associated with the consumption of contaminated produce.

This rule is effective January 26, 2016. The effective date of Sec. Sec. 117.5(k)(2), 117.8, 117.405(c), 117.410(d)(2)(ii), 117.430(d), and 117.475(c)(13) published September 17, 2015 (80 FR 55908), is January 26, 2016. The effective date of Sec. Sec. 507.12(a)(1)(ii), 507.105(c), 507.110(d)(2)(ii), 507.130(d), and 507.175(c)(13) published September 17, 2015 (80 FR 56170), is January 26, 2016. See section XXIV of this document for the compliance dates. The incorporation by reference of certain publications listed in this rule is approved by the Director of the Federal Register as of January 26, 2016. Samir Assar, Center for Food Safety and Applied Nutrition (HFS-317), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 240-402-1636. 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